San Francisco-based Medivation Inc. and Astellas Pharma Inc. had plenty to celebrate heading into the Labor Day holiday weekend. The FDA on Friday approved Xtandi (enzalutamide) capsules for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously received docetaxel three months ahead of the product's prescription drug user fee goal date of Nov. 22. Read More
The recent spate of setbacks for competitors working in hepatitis C virus (HCV) has proved good news for Achillion Pharmaceuticals Inc., which took the opportunity to shore up its balance sheet with a $41.8 million offering. Read More
The diabetes arsenal is chock full of marketed therapies – glucagon-like peptide-1 agonists, dipeptidyl peptidase-4 inhibitors and the so-called "glitazones" to name a few (though the latter has suffered from safety concerns over the past few years) – but the space has seen a shortage of promising new targets. Read More
Novartis AG hopes to show an FDA advisory committee that it can teach a new trick to an old dog to make management of Pseudomonas aeruginosa easier for cystic fibrosis (CF) patients. Read More
• Cell Therapeutics Inc., of Seattle, said that it filed with the secretary of state for the State of Washington an amendment to its amended and restated articles of incorporation to implement a 1-for-5 reverse stock. CTI's total number of authorized shares will be decreased from 384,999,999 shares to 76,999,999 shares. Read More
• Sophiris Bio Inc., of La Jolla, Calif., reported data from a Phase I/II safety study, in which PRX302 was well tolerated through three months following a transrectal injection. Read More
• Janssen-Cilag International NV, of Beerse, Belgium, a unit of Johnson & Johnson, submitted a marketing authorization application to the European Medicines Agency seeking conditional approval for the use of TMC207 (bedaquiline) as part of combination therapy for pulmonary, multidrug-resistant tuberculosis (MDR-TB). Read More
In results that differ partially from those previously published by another group, a team from the National Institutes of Health (NIH) has reported that caloric restriction did not increase the life span of rhesus monkeys, regardless of whether such caloric restriction began when the animals were young, middle age or elderly. Read More
